Can risedronate prevent periprosthetic bone loss after hip arthroplasty?A randomized, double-blind, placebo-controlled trial - PREVENT

Conditions: Periprosthetic bone loss after total hip arthroplasty (THA) is the main factor in limiting the longevity of implants used för treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA may prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthetic loosening. We want to perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss.

Registration Number: EUCTR2004-002965-19-SE

Lead Sponsor: Orthopaedic department, Karolinska Institutet, Danderyd's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients waiting for total hip arthroplasty due to primary or secondary osteoarthritis of the hip.

Patients between 40-70 years of age.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with rhematoid arthritis or earlier infection of the hip
Steroid treatment
Bisphosphonate treatment
Osteomalacia
Hypocalcemia
Pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Can risedronate given once weekly (35 mg) prevent periprothetic bone loss after uncemented total hip arthroplasty?;Secondary Objective: Can risedronate prevent loosening of the prosthesis and reduce the number of reoperations?;Primary end point(s): Periprosthetic bone remodeling quantified by dual-energy x-ray absoptiometry.

Secondary Outcome Measures